This trial is active, not recruiting.

Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will
evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease
remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and
at least one second controller medication. Participants will be randomized in 1:1:1 ratio to
receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo,
administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their
standard-of-care therapy. This will be followed by a 52-week double-blind active treatment
extension. During double-blind active treatment extension period, all participants will
receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study
treatment is 104 weeks. After study treatment, all participants will complete a 20-week
safety follow-up.

Participants will receive SC injection of lebrikizumab matching placebo every 4 weeks for 52 weeks during placebo-controlled period and then SC injection of lebrikizumab at 125 or 37.5 mg for 52 weeks during active treatment extension period.

lebrikizumab
RO5490255

Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.

placebo

Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.

Primary Outcomes

Measure

Rate of Asthma Exacerbations During the 52-Week Placebo-Controlled Period

time frame:
Baseline up to 52 weeks

Secondary Outcomes

Measure

Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

time frame:
Baseline, Week 52

Time to First Asthma Exacerbation

time frame:
Baseline up to 52 weeks

Change From Baseline in Standardized Asthma Quality of Life Questionnaire (AQLQ) Score

time frame:
Baseline, Week 52

Change from Baseline In Asthma Rescue Medication (Number of Puffs or Nebulized Treatments)

time frame:
Baseline, Week 52

Rate of Urgent Asthma-Related Urgent Health Care Utilization

time frame:
Baseline up to Week 52

Percentage of Participants With Anti-Therapeutic Antibodies to Lebrikizumab

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria:
- Asthma diagnosis for greater than equal to (>/=) 12 months prior to Visit 1
- Bronchodilator response at Visit 1, 2, or 3
- Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
- On ICS therapy at a total daily dose of 500-2000 micrograms (mcg) of fluticasone
propionate dry powder inhaler (DPI) or equivalent for >/=6 months prior to Visit 1
- On an eligible second controller medication (long-acting beta-agonist [LABA],
leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or
theophylline) for 6 months prior to Visit 1
- Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
- Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or
chest X-ray during the screening period (prior to Visit 3) confirming the absence of
other clinically significant lung disease
- Demonstrated adherence with controller medication during the screening period
Exclusion Criteria:
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or
known hypersensitivity to any component of the lebrikizumab injection
- Maintenance oral corticosteroid therapy within 3 months of Visit 1
- Treatment with systemic (oral, intravenous [IV], or intramuscular [IM])
corticosteroids within 4 weeks prior to Visit 1 or during the screening period
- Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or
during the screening period or anticipated need for intra-articular corticosteroids
during the course of the study
- Infection requiring hospital admission for >/=24 hours or requiring treatment with IV
or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower
respiratory tract infection within 4 weeks prior to Visit 1 or during screening;
Active infection that required treatment with oral antibiotics within 2 weeks prior
to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes
infection within 6 months prior to Visit 1 or during screening
- Active tuberculosis requiring treatment within 12 months prior to Visit 1
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus
(HIV) infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD),
or other clinically significant lung disease other than asthma
- Known current malignancy or current evaluation for potential malignancy
- Current smoker or former smoker with a history of greater than (>) 10 pack-years
- History of alcohol or drug abuse
- Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy,
including lebrikizumab
- Use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5
drug half-lives prior to Visit 1 (whichever is longer) or during screening
- Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or
during screening

Additional Information

Official title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.